For people living with diabetes, daily reliable insulin delivery is essential. The Ominpod insulin pump system, a well-known device for managing diabetes, is currently under scrutiny due to a series of medical device recalls. On May 26, 2026, both Insulet Corporation and Health Canada issued recalls related to the following affected products (“the Omnipod devices”):
- Omnipod 5 Automated Insulin Delivery System
- Omnipod 5 Pod
- Omnipod DASH
- Omnipod DASH, Pods 10-Pack
- Ominpod Insulin Management System – Omnipod
The recalls stem from a manufacturing defect that can compromise insulin delivery, potentially leading to severe and life-threatening health complications for diabetes patients who use the Omnipod devices.
Understanding the Omnipod System.
The Omnipod pump is a wearable insulin delivery device used by people with diabetes. The device is worn directly on the body and is designed to deliver insulin continuously to its user, reducing the need for multiple daily injections.
Insulet Corporation is the company that manufactures and distributes Omnipod insulin pump products. These products include the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH, and Omnipod Eros-style products, which have been authorized for sale in Canada since 2009. The Omnipod DASH became commercially available in Canada in January 2021, and the Omnipod 5 received Health Canada approval in 2024, becoming commercially available in April 2025.
The Alarming Defect and Its Consequences.
The core issue is a manufacturing defect in the Omnipod tube related to tears in the external (exposed) soft cannula. This defect may result in a compromised fluid path leading to reduced or interrupted insulin delivery. This can cause high blood glucose levels (hyperglycemia) and in severe cases, this can escalate to diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition that requires hospitalization.
Many diabetes patients rely on insulin pump systems as part of their daily medical care. A defect that interferes with insulin delivery may not always be obvious to the user. Some users may notice wetness on their skin or pod adhesive or detect the smell of insulin. In other cases, the issue may go unnoticed until symptoms become more serious.
Investigation Into Legal Claims.
Gluckstein Lawyers is investigating potential claims against Insulet Corporation that may include allegations of negligence, failure to warn, breach of warranty and claims under provincial consumer protection legislation. These claims may focus on whether the manufacturer took reasonable steps in the design, manufacturing, quality control, distribution, sale, monitoring, and warning of risks associated with the device.
Advice for Canadian Users.
While it is unclear how many Canadians use the Omnipod devices, it is offered across Canada and has become a common device for insulin delivery. As part of our firm's class action and mass tort litigation team, I urge those who have used the recalled Omnipod devices or are still using them to take action immediately.
Contact our team of Toronto personal injury lawyers at Gluckstein Lawyers for a free consultation if you have used the Omnipod devices and have experienced serious health issues, such as high blood glucose, DKA, or hospitalization. We can help.
Manufacturers of medical devices have a significant responsibility to ensure the safety of their products and to adequately warn consumers of any dangers. In some cases, lives and people's wellbeing are at stake and these manufacturers must be held accountable to make sure we can rely on medical devices we are taking now and in the future.
Disclaimer.
This blog post is for general informational purposes only and does not constitute legal or medical advice. Reading this post or contacting the firm does not create a lawyer-client relationship. Each potential claim will be assessed on its individual facts and merits.